NCT05974293

A Phase IIb Study of Nabiximols for Spasticity Due to Neuromyelitis Optica Spectrum Disorders

A Phase IIb Study of the Safety and Efficacy of Nabiximols in Subjects With Spasticity Due to Neuromyelitis Optica Spectrum Disorders: A Double-blind, Randomized, Placebo-Controlled, Crossover Study

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Michael, Levy M.D.,Ph.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the safety and efficacy of nabiximols, a cannabinoid spray, for the treatment of moderate to severe spasticity in adult patients with AQP4-IgG positive and antibody-negative NMOSD. The main question it aims to answer is whether treatment with nabiximols improves patient-reported spasticity ratings compared to treatment with a placebo. This trial will also answer whether nabiximols impact pain, spasm frequency, mood, walking ability, and sleep. Participants will be mailed the treatments and placebo treatments, and will be asked to complete study visits and questionnaires remotely. There is also an optional sub-study that involves in-person visits with ultrasound imaging and in-person neurologic exams.

Detailed description

Patients with NMOSD often have medication-resistant and severe spasticity due to longitudinally extensive spinal cord lesions. Existing treatments are limited by their efficacy and tolerability. Cannabinoids have been shown to quantitatively improve spasticity in mouse models of neuroinflammation, and nabiximols, a cannabinoid-based oromucosal spray, have demonstrated efficacy for medication-resistant spasticity in multiple sclerosis. However, no studies have as yet explored the use of nabiximols specifically in NMOSD, and there is a significant unmet need for new symptomatic treatments in this patient population. The goal of this study is to evaluate the safety and efficacy of nabiximols spray, for the treatment of moderate to severe spasticity in adult patients with AQP4-IgG positive and seronegative NMOSD. This study is designed as a phase IIb, single-site, double-blind, randomized, placebo-controlled 2x2 crossover clinical trial, with a 2-week washout period between treatment periods. After randomization, each participant enters into Period 1, which begins with a 2-week dose escalation period with a pre-defined dose escalation scheme, followed by a 4-week stable treatment period. After completion of Period 1, all participants have a 2-week washout period and then enter Period 2, where they again complete a 2-week dose escalation period and 4-week constant treatment period. The patient-reported 0-10 numeric rating scale for spasticity (NRS-S) is the primary outcome measure. All key study procedures are performed virtually, including a weekly electronic study diary, additional weekly surveys, and 8 virtual video-based study visits including a screening visit and safety follow up visit. Additional optional in-person assessments of spasticity (neurologic exam, modified Ashworth Scale and muscle ultrasound elastography) will be performed for a selection of local participants. In total, the study has a 20-week duration per participant, from the screening visit to the final study completion for safety follow-up visit, including 12 weeks of on-treatment time.

Conditions

• NMO Spectrum Disorder
• Spasticity, Muscle

Interventions

Type	Name	Description
DRUG	Nabiximols	Nabiximols is is a yellow-brown oromucosal spray solution containing 27 mg/mL of THC and 25 mg/mL of CBD.
DRUG	Placebo	The placebo is a matching oromucosal spray that is identical to the investigational study product in terms of packaging, labelling, schedule of administration, dosing instructions, and appearance.

Timeline

• Start date: 2026-12-31
• Primary completion: 2027-04-30
• Completion: 2027-09-30
• First posted: 2023-08-03
• Last updated: 2025-07-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study